System and method for laboratory-based authorization of genetic testing

ABSTRACT

System and methods for providing laboratory-based authorization of genetic testing are disclosed. An order for genetic testing is received from an electronic health record (“EHR”) system at a laboratory information system (“LIS”). A prior authorization request is automatically generated at the LIS from data parsed from the order and retrieved from the EHR and sent to a prior authorization provider. If a patient responsibility amount returned to the LIS is below a threshold, testing proceeds. If the patient responsibility amount is above the threshold, an electronic call center request is generated and the patient is contacted to obtain payment. If a billing consent is not obtained, the specimen for the order is destroyed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. application Ser. No.16/674,189 filed Nov. 5, 2019, which is a continuation-in-part of U.S.application Ser. No. 16/441,597 filed Jun. 14, 2019, which claims thebenefit of U.S. Provisional Application Ser. No. 62/685,479 filed Jun.15, 2018 and U.S. Provisional Application Ser. No. 62/773,424 filed Nov.30, 2018, the disclosures of all of which are hereby incorporated byreference as if fully restated herein.

TECHNICAL FIELD

Exemplary embodiments relate generally to systems and methods forlaboratory-based authorization of genetic testing.

BACKGROUND AND SUMMARY OF THE INVENTION

A person visiting a doctor may present with one or more symptoms. Basedon the symptoms presented, test results, or underlying conditions ordiseases diagnosed, the person may be prescribed one or more medicationsor other treatment options by the healthcare provider as part of atreatment program. These prescribed treatments may be selected based onthe historical effectiveness of such treatment options against thesymptoms presented by the person and/or the underlying disease(s) orcondition(s) diagnosed by the healthcare provider. Traditionally, theprescription of treatment options is, at least initially, based onhistorical effectiveness of certain medications against the diagnoseddisease. Individual prescriptions may be altered through a trial anderror process following the initial prescription. For example,alternative medications, dosages, or other treatments (e.g., surgery,herbal remedies, other therapies) may be prescribed where theprescription of a particular treatment option causes a side effect orallergic reaction in a patient and/or simply fails to achieve thedesired outcome. Over prescription or dosing of treatments, particularlyof medications, may cause side effects or other undesirableconsequences. Under prescription or dosing of treatments, particularlyof medications, may bring about ineffective results, side effects, orother undesirable consequences.

A person's genetic makeup often affects how the person responds tocertain medical treatments, such as the administration of medications.For example, a person's genetic makeup may cause some medications ordosages to be wholly or partially ineffective. As a further example, aperson's genetic makeup may make surgery more or less desirable.Prescription of treatments to a person who has a genetic makeup thatmakes the treatment wholly ineffective may waste resources andunnecessarily expose the person to the risk of side effects. Similarly,prescription of treatments to a person who has a genetic makeup thatmakes the treatment partially ineffective may result in less thandesirable therapeutic effects, require a larger dosage, or the like tobe effective. In some cases, alternative medications, dosages, or othertreatment options are available for use with the same, or similar,therapeutic effects.

For example, without limitation, a blood thinner may be known to reducethe risk of embolisms and may be prescribed to a person following stentplacement. However, the patient's individual genetic makeup orphysiology may alter the effectiveness of the prescribed blood thinner.For example, without limitation, the blood thinner may have a reducedeffectiveness in persons carrying specific genetic markers. It would bedesirable to substitute alternative medications or adjust the dosage ofprescribed medications for persons having a genetic makeup which reducesthe effectiveness of the prescribed medication. As a further example,again without limitation, the prescribed blood thinner may be whollyineffective in persons carrying specific genetic markers. It would bedesirable to substitute alternative medications, or find alternativetreatment options, for persons having a genetic makeup which renders theprescribed medication ineffective. Therefore, what is needed is a systemand method for determining the effectiveness of medications usinggenetics.

A persons' genetic makeup may determine the efficacy of other treatmentsbeyond just medications. For example, without limitation, a persons'genomic makeup may be analyzed to determine the efficacy of variouscancer treatment options. Such options may include various medications,such as chemotherapy, but may also include surgery, radiation, activesurveillance, and other treatment approaches.

Current systems, such as electronic medical record systems (“EMRs”), areoften unable to accept genomic information in a meaningful way and/orlack a dedicated space for such genetic information. For example, EMRsoften do not have a designated page, portal, display, or the like forgenomic testing results to be displayed. Therefore, what is needed is asystem and method for integrating genetic efficacy information withexisting systems.

Being a cutting-edge field, genomics testing is often not part of ahealthcare provider's routine care plan. A healthcare provider may noteven be aware that certain genomic testing is available that candetermine the efficacy of various treatment options, such asmedications. Therefore, what is needed is a system and method fordetermining eligibility for genetic efficacy testing.

These disclosures provide systems and methods for determining theeffectiveness of treatment options, such as medications, using geneticdata. A user's visit information may be reviewed to identify applicabletests. For example, such tests may indicate the presence or non-presenceof genetic markers which may indicate a genetic makeup for a patientthat may have a bearing on the effectiveness of one or more treatmentsprescribed, and/or likely to be prescribed, to the user.

The disclosed systems and methods may be applied to any number ofgenomic efficacy tests. For example, without limitation, genomic testingmay be ordered to determine the patient's likelihood of developingcertain cancers and/or the efficacy of various treatment options fordifferent types of cancer.

The disclosed systems and methods may streamline the ordering andeligibility process. The system may be configured to determine whetheridentified tests fit certain billing parameters. For example, the systemmay be configured to determine whether the identified tests are coveredby the user's insurance. If the test for one or more markers does notfit the billing parameters, then the next genetic marker(s) may beconsidered. If the test does fit the billing parameters then the optionto order testing may be presented to the healthcare provider. Ifselected, the appropriate marker(s) may be added to a testing device andthe genetic testing may be performed. In exemplary embodiments,diagnostic and treatment codes may be entered by the healthcare providerinto their system. A determination may be made as to whether certaingenetic efficacy testing meets various insurance eligibility criteria,such as but not limited to, medically necessary criteria. If so, therespective genomic tests may be automatically added to an order list. Inthis way, all available testing for which the patient is eligible may beautomatically added to an ordering list, thereby increasing theavailability of potentially relevant information to the healthcareprovider. The order list may be subsequently displayed to the healthcareprovider for confirmation, though in other exemplary embodiments theorder list may be automatically processed.

To perform the testing, genetic material may be removed from the user. Atesting device may be created to test for the specific genetic marker(s)ordered. The genetic material may be sequenced using the testing deviceand the presence or non-presence of the tested genetic markers may bedetermined. The results may be analyzed and ineffective treatmentoptions, such as but not limited to medications, may be identified. Inexemplary embodiments, for each treatment prescribed or likely to beprescribed, the presence or non-presence of one or more genetic markersmay be analyzed and compared against the treatments known to beeffective or ineffective in the presence of the given marker. Effectivetreatments and/or dosages may be identified. Alternatively, oradditionally, ineffective treatments and/or dosages may be identified.For those treatments and/or dosages determined to be ineffective,alternative medications, dosages, and/or treatment options may besuggested.

Integration into existing EMRs, electronic health records (“EHR”), andother healthcare provider systems may be performed by designatingineffective medications or other treatment options as an allergy in theuser's file. This may provide a pathway for integration with existingEMRs, EHRs, and other healthcare provider systems. Advantageously, inexemplary embodiments, this solution may configure the EMR, EHR, orother healthcare provider system to generate an alert upon selection ofa medication or other treatment options designated by the testingresults to be ineffective. In this way, the disclosed systems andmethods may be integrated within the framework of existing systems toprevent the costs and complexities of redesigning the existing systems.

Regardless, the testing results may be returned to the healthcareprovider's system. For example, treatment of a particular disease maynormally first begin with medication. However, if the person has agenetic makeup which would make such medication ineffective, a surgicaloption may instead be suggested.

The results may be returned to the healthcare provider in the form of aninterface for display on an electronic display. The results may bedisplayed in a fashion which provides the clinical consequences ofprescribing the treatment. The interface may further provide indicationsof particular conditions and generate alerts when particular conditionsare met. For example, without limitation, executable softwareinstructions may be provided which configure the electronic display todisplay an interface comprising an explanation of the results, alerts,abnormal ranges, ineffective treatments, potential interactions asunderstood in view of the analyzed genetic information, and otherclinical information. This information may be transmitted with theresults in a single file.

In exemplary embodiments, these results and alerts may be integratedinto the healthcare providers' EHR by way of a single file, thoughmultiple files may be utilized. In exemplary embodiments, the results ofthe ordered tests, including but not limited to the ineffectivetreatment options, may be transmitted to a healthcare informationexchange (“HIE”). The HIE may subsequently distribute the results to anumber of linked healthcare provided systems and/or make such dataavailable for access. This information may be further transmitted to anynumber of healthcare provider facilities, such as but not limited tohospitals, by way of one or more HIEs. For example, information may betransmitted to all healthcare providers treating the user. The resultsmay also be stored for use by, and selective transmission to, futurehealthcare providers. In this way, the disclosed systems and methods mayintegrate with existing healthcare provider systems, such as EHRs andHIEs to facilitate the ordering of such genomic efficacy tests andintegrate the results into the framework of existing systems.Furthermore, integration with a number of healthcare provider systemsmay be accomplished by integration with one or more HIEs.

Genetics testing, such as but not limited to genetics-based medicationefficacy testing, is a burgeoning field. Not all payors support genetictesting, and those that do often have specific rules regarding whichtypes of testing are covered and which are not. Conventionally, todetermine if the genetic testing will be covered, a representative of ahealthcare provider's office contacts a patient to obtain certaininformation, which is then passed to the payor for prior authorizationof the proposed genetic tests. This work is taxing on patients andhealthcare provider office staff. It also results in duplicateinformation being generated for prior authorization purposes andlaboratory ordering purposes. Furthermore, the patient sometimes owes acopay, and the healthcare provider's office is further burdened withcollecting payment from the insured, paying the laboratory for testing,and collecting amounts owed from the patient. This results in complexmanagement and transfer of funds.

Laboratories typically do not have sufficient information or resourcesto perform the prior authorization request. For example, withoutlimitation, the laboratory may not have access to the patient's healthhistory such as but not limited to disease diagnosis and activemedications, which are sometimes required to determine if the orderedgenetic testing is medically necessary. Therefore, what is needed is asystem and method for laboratory-based authorization of genetic testing.

Systems and methods for automatically providing laboratory-basedauthorization of genetic testing are provided. An order may be generatedat a healthcare provider's EHR or other system. The order may beinitiated by a healthcare provider and may be based on suggested ordersfrom the laboratory. A specimen for testing may be sent from thehealthcare provider to the laboratory. The order information may be sentelectronically from the healthcare provider's office system or EHR to alaboratory information system (“LIS”) associated with a laboratory. TheLIS may automatically parse information from the order. The LIS may bein electronic communication with the EHR and electronically retrievecertain patient health information.

The LIS may use the parsed order data and/or retrieved healthinformation to automatically generate an electronic prior authorizationrequests which may be electronically transmitted to the appropriateparty for communication and/or approval. The appropriate party mayinclude, for example without limitation, the payor, the call center, aprior authorization provider, some combination thereof, or the like. Theappropriate party may return a reference ID and a patient responsibilityamount. The patient responsibility may represent an amount owned by thepatient such as, but not limited, to a copayment, deductible,coinsurance, some combination thereof, or the like. If the patientresponsibility exceeds a predetermined threshold, a call center noticemay be automatically generated and transmitted to the laboratory and/ora call center. The call center and/or laboratory may contact the patientto obtain a virtual billing consent to proceed. The virtual billingconsent may be consistent with a signed informed billing consentpresented to the patient in the office at the time of the testing isordered and/or the genetic material is gathered. If consent is denied,or if a predetermined number of attempts are made to contact the patientwithout success, the specimen may be destroyed and the order terminated.If consent is received, payment may be collected, such as in real timewhen obtaining the virtual billing consent, and the testing may beallowed to proceed. If the patient responsibility is below thepredetermined threshold, testing may proceed. Testing results may begenerated and transmitted to the healthcare provider. In exemplaryembodiments, the prior authorization and virtual billing consent processmay be completed while the specimen is in transit to the laboratory.

While all types of genetic testing are contemplated, certain advantagesmay be realized in particular for genetics-based medication efficacytesting. For such testing, the LIS may query the EHR to obtain a list ofactive medications. Alternatively, or additionally, the LIS may querythe EHR to obtain a list of diagnoses and use that list to generate alist of medications likely to be prescribed to the patient. The efficacyof one or more of the listed medications may be tested. This same listof medications and/or diagnoses may be used in making priorauthorization decisions, for example without limitation, to determinewhich tests are medically necessary. Thus, in at least one embodiment,the invention improves the processing capabilities and speed byeliminating duplicate information and reducing burdens on electronicstorage.

Electronic funds management is another technological challenge. Underconventional approaches, the healthcare provider acts as a collector andpayor for the laboratory, whose is the driver of fees for the testing.By utilizing the laboratory to directly obtain prior authorization andcollects funds, the complexity and challenges of electronic fundsmanagement and transfer are significantly reduced or eliminated. Thismay reduce the number of potential security intrusion standpoints, thenumber of parties needing to secure financial information, the number offunds transfers, and the like. It also may place the collection risk onthe laboratory instead of the healthcare provider.

The disclosed systems and methods may reduce the number of humaninteractions required, thereby improving data processing times and/oraccuracy. The electronic automation may result in faster, more accurate,and more consistent data processing. The disclosed systems and methodsmay reduce the amount of paper transferred, data faxed, telephone callsmade, voicemails recorded, and the like, all of which may serve asadditional points to data intrusion. In this way, the communicationpipeline may be streamlined to reduce the number of access points andimprove data security. The disclosed systems and methods may reduce theneed for resources at the healthcare provider office reducing businesscosts and complexity.

Further features and advantages of the devices and systems disclosedherein, as well as the structure and operation of various aspects of thepresent disclosure, are described in detail below with reference to theaccompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

In addition to the features mentioned above, other aspects of thepresent invention will be readily apparent from the followingdescriptions of the drawings and exemplary embodiments, wherein likereference numerals across the several views refer to identical orequivalent features, and wherein:

FIG. 1A is a simplified illustration of a DNA helix;

FIG. 1B is a simplified illustration of a DNA sequencing test result;

FIG. 2 is a simplified perspective view of an exemplary genetic materialgathering device and an exemplary sequencing device;

FIG. 3 is a simplified perspective view of an exemplary genetic testingdevice for use with the sequencing device of FIG. 2;

FIG. 4A is a simplified plan view of an exemplary system for providinggenetic efficacy testing results, including the sequencing device ofFIG. 2;

FIG. 4B is a flow chart with exemplary logic for distributing the testresults;

FIG. 5A is a flow chart illustrating exemplary logic for identifying,ordering, and performing tests;

FIG. 5B is a flow chart illustrating other exemplary logic foridentifying and ordering tests;

FIG. 6A is a flow chart illustrating exemplary logic for performinggenetic efficacy testing and analyzing results;

FIG. 6B is a flow chart illustrating exemplary logic for integratinggenetic efficacy test results within existing systems;

FIG. 7 is an exemplary healthcare provider interface;

FIG. 8 is a simplified block diagram illustrating exemplary logic foranalyzing genetic efficacy test results and generating alerts;

FIG. 9 is an exemplary laboratory-based prior authorization system inaccordance with the present invention; and

FIG. 10 in a flowchart with exemplary logic for operating the system ofFIG. 9.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)

Various embodiments of the present invention will now be described indetail with reference to the accompanying drawings. In the followingdescription, specific details such as detailed configuration andcomponents are merely provided to assist the overall understanding ofthese embodiments of the present invention. Therefore, it should beapparent to those skilled in the art that various changes andmodifications of the embodiments described herein can be made withoutdeparting from the scope and spirit of the present invention. Inaddition, descriptions of well-known functions and constructions areomitted for clarity and conciseness.

FIG. 1A is a simplified illustration of a DNA helix 4. DNA, ordeoxyribonucleic acid, is a double-helix shaped chain of nucleotidesthat carry the genetic instructions used in the growth, development,functioning, and reproduction of all known living organisms. There arefour major types of nucleobases in any nucleotide of a DNA sequence,which are generally coded as A, T, C, and G for adenine, thymine,cytosine, and guanine, respectively. Each individual human is believedto have a unique DNA structure that defines the persons' genetic makeup.

FIG. 1B is a simplified illustration of a DNA sequencing test result 6.Upon sequencing of the DNA 4, the presence or non-presence of particularnucleobases (A, T, C, or G) may be detected. The presence andnon-presence or order of such nucleobases can be used to determine thepresence or non-presence of certain genetic markers. The genetic markersmay indicate the existence or non-existence of certain genetic traitsfor the person.

FIG. 2 is a simplified perspective view of an exemplary genetic materialgathering device 10 and an exemplary genetic sequencing device 20. Thegenetic material gathering device 10 may comprise a swab, syringe, vial,strip, or the like. For example, without limitation, the geneticmaterial gathering device 10 may comprise a swab configured to be usedon the inside of the user's cheek to gather saliva and/or skin cells. Inother examples, without limitation, the genetic material gatheringdevice 10 may comprise a syringe configured to gather blood, a vialconfigured to store blood, hair, skin samples, or the like, somecombination thereof, or the like. Any type of genetic material gatheringdevice 10 for gathering any type of genetic material is contemplated.

The genetic sequencing device 20 may comprise any kind of deviceconfigured to sequence genetic material. In exemplary embodiments, thegenetic sequencing device 20 may comprise a loading area 22 and acontrol panel 24. The loading area 22 may be configured to accept one ormore testing devices 30. The control panel 24 may be integrally formedwith the genetic sequencing device 20 or may be a separate electronicdevice in communication with the genetic sequencing device 20. Thecontrol panel 24 may be configured to accept user input comprisinginstructions for carrying out various genetic tests on the testingdevice 30. The control panel 24 may be configured to display the resultsof such testing. Such instructions may, alternatively or additionally,be accepted from a remote device, which may comprise the control panel24 or another device. Testing results may be transmitted to one or moreremote devices and/or systems as further described herein.

FIG. 3 is a simplified perspective view of an exemplary genetic testingdevice 30 for use with the sequencing device 20. In exemplaryembodiments, the testing device 30 may comprise a chip 31 comprised of anumber of wells 32, though any type of testing device 30 iscontemplated. Each of said wells 32 may be configured to test for aparticular genetic marker. The testing device 30 may be configured toaccommodate any number of wells 32. In exemplary embodiments, certainwells 32 may be added or removed from the testing device 30 in order totest for the presence or non-presence of various genetic markers. Forexample, without limitation, wells 32 may be added to the chip 31 totest for particular genetic traits and wells 32 may be removed from thechip 31 if a particular genetic trait is not being tested for. In stillother exemplary embodiments, the wells 32 being used may be placed in anunblocked position such that genetic material may enter the well 32.Similarly, the wells 32 not being used may be placed in a blockedposition such that genetic material may not enter the wells 32.Modifications to the testing device 30 may be performed manually orautomatically based on the instructions for testing received. Forexample, without limitation, the testing device 30 may be constructed ormodified by one or more robots. The testing device 30 may furthercomprise one or more areas 33 to affix labels, markers, or the like, andmay comprise, for example without limitation, unique identifiers,barcodes, QR codes, some combination thereof, or the like.

FIG. 4A is a simplified plan view of an exemplary system for providinggenetic efficacy testing results. The genetic sequencing device 20 maybe in electronic communication with a laboratory system 40. Thelaboratory system 40 may receive testing instructions which arecommunicated to one or more genetic sequencing devices 20. Thelaboratory system 40 may also be configured to receive the results ofany performed tests from the one or more genetic sequencing devices 20.More than one laboratory system 40 may be provided, each of which may bein communication with one or more genetic sequencing devices 20. Inexemplary embodiments, the laboratory system 40 may be a laboratoryfacing system, such as but not limited to a laboratory informationsystem (“LIS”). The laboratory system 40 may be in electroniccommunication with one or more healthcare provider systems 50. Each ofthe healthcare provider systems 50 may comprise patient information, alist of ordered tests, and test results, among other data. Thehealthcare provider systems 50 may communicate instructions for geneticefficacy tests to be performed to the laboratory system 40. The resultsof such ordered genetic efficacy tests may be transmitted from thelaboratory system 40 to one or more of the healthcare provider systems50. In exemplary embodiments, the healthcare provider systems 50 may behealthcare provider facing system such as, but not limited to, anelectronic medical record (“EMR”) system, electronic health record(“EHR”), some combination thereof, or the like. Although someembodiments are discussed with respect to a certain number of geneticsequencing devices 20, laboratory systems 40, and healthcare providersystems 50, any number of such components are contemplated.

The sequencing device 20, the laboratory system 40, and the healthcareprovider system 50 may be located in the same facility, or may be remotefrom one another. The electronic communication may be by way of a wiredor a wireless connection. The electronic communication may further bemade by way of one or more network interface devices and one or morecommunication networks located at each of the sequencing device 20, thelaboratory system 40, and the healthcare provider system 50. Thecommunications networks utilized may include, but are not limited to,the internet, intranet, cellular network, or the like. In exemplaryembodiments, communications between the genetic sequencing device 20,the laboratory system 40, and/or the healthcare provider system 50 maybe made secured and encrypted. Alternatively, or additionally, suchcommunications may be made in a standardized format such as, but notlimited to, a HL7 format. In exemplary embodiments, the genetic efficacytest results may be pulled from the laboratory system 40 such as, butnot limited, to by the use of scanning and archiving software. Thetesting results may be automatically integrated into the healthcareprovider system 50. Such integration may be performed by way of a flatfile, though any method of integration is contemplated. For example,without limitation, the testing results may be automatically integratedinto the EHR utilized by the healthcare provider, preferably as furtherdescribed herein.

Alternatively, or in addition, the test results may be made available tothe healthcare provider by way of an internet-based portal accessedthrough the healthcare provider system 50 or any number of personalelectronic devices 51 in electronic communication with, or constituting,the healthcare provider system 50. In particular, a hyperlink to theportal may be provided to the healthcare provider system 50 such that itis stored as a quick link access, though such is not required. As yetanother example, without limitation, the testing results may be providedto the healthcare provider by way of email to the healthcare providersystem 50. In other embodiments, the testing results may be madeavailable to the healthcare provider by way of an application installedon the various personal electronic devices 51.

The test results stored on the laboratory system 40 may be secured suchthat a particular healthcare provider can only access the results forusers associated with the particular healthcare provider. For example,without limitation, permission may be set such that login credentialsassociated with a given healthcare provider may be permit access to testresults for particular users associated with that healthcare provider.The laboratory system 40 may be configured to periodically downloadtesting results from the genetic sequencing device 20. Similarly, thelaboratory system 40 may be configured to periodically download testingresults to the healthcare providers system 50. Alternatively, or inaddition, certain results may be downloaded on demand. Access to thetesting data, including but not limited to testing results, may beprotected by way of security protocols, such as, but not limited to,authentication, biometric scanning, single sign-on, barcode scanningprotocols, some combination thereof, or the like. The automation andreduction in human interaction provided by the disclosed systems andmethod may reduce the number of potential intrusion points and improvedata security.

Each of the sequencing devices 20, the laboratory systems 40, and thehealthcare provider systems 50 may comprise one or more electroniccomponents. Such electronic components may include, but are not limitedto, processors, electronic storage devices, user input devices,displays, and the like. Each of the sequencing devices 20, thelaboratory systems 40, and the healthcare provider systems 50 maycomprise software instructions configured to perform the steps andfunctions described herein.

FIG. 4B is a flow chart with exemplary logic for distributing thegenetic efficacy test results. In exemplary embodiments, test resultsmay be received from the laboratory system 40 at a health careinformation exchange (“HIE”) 55. The HIE 55 may be in electroniccommunication with a number of healthcare provider systems 50. Each ofthe healthcare provider systems 50 may be in electronic communicationwith one or more personal electronic devices 51. The HIE 55 may beconfigured to automatically distribute the test results to eachhealthcare provider system 50 associated with a healthcare providerknown to be treating the patient. In other exemplary embodiments, theHIE 55 may make the testing results available for integration into anyof the linked healthcare provider systems 50.

In exemplary embodiments, the necessary integration of the laboratorysystem 40 and/or genetic efficacy test results may be performed onlywith respect to a single HIE 55 to permit integration with a number oflinked healthcare provider systems 50. This also may permit informationfor specific data, such as but not limited to unusual cases, to beshared across healthcare providers who may be geographically remote fromone another and/or associated with different practices such that themost relevant information may be made available to healthcare decisionmakers. For example, without limitation, the efficacy data for a patientseen with a relatively rare genetic makeup in Connecticut may be sent toa doctor in Oregon who has a different patient with a similar geneticmakeup.

FIG. 5A is a flow chart illustrating exemplary logic for identifying,ordering, and performing genetic efficacy tests. A user may visit one ormore healthcare providers and present with a variety of symptoms. As thehealthcare provider evaluates the user, including by taking a medicalhistory, evaluating symptoms, and performing tests, the healthcareprovider may enter information about the user into the healthcareproviders' system 50. Already existing information about the user mayalready be present on the healthcare providers' system 50, though suchis not required. Such information already existing or entered by thehealthcare provider might include, for example but without limitation,identification information, demographic information, insuranceinformation, medical history, known allergies, family history, somecombination thereof, and the like. In exemplary embodiments, thehealthcare provider system 50 comprises an EMR and/or an EHR. Theentered information by the healthcare provider at a given visit mayinclude, for example but without limitation, treatment actions taken orprescribed, symptoms presented, diagnosed diseases or conditions, testsordered, testing results, some combination thereof, and the like. Inexemplary embodiments, at least the treatment actions taken orprescribed and the diseases or conditions diagnosed may be enteredand/or converted into codes, such as but not limited to, ICD codes,though any type, protocol, or format of coding is contemplated.

In exemplary embodiments, certain information about the patient may beretrieved by the laboratory system 40 from the healthcare providersystem 50 such as, but not limited, to by the use of scanning andarchiving software. The laboratory system 40 may review the enteredinformation and identify conditions diagnosed, or likely to bediagnosed, treatments prescribed, or likely to be prescribed, to thepatient. The treatments likely to be prescribed, such as but not limitedto medications, may be determined by comparing the entered informationwith standard treatment procedures. Such standard treatment proceduresmay be stored at the laboratory system 40, or at one or more separatedatabases, and may be sourced from public and private data sources. Forexample, without limitation, if a stent placement is ordered for thepatient, the laboratory system 40 may determine that post-operativeblood thinners are likely to be prescribed. The conditions likely to bediagnosed may be determined by comparing the entered information, suchas symptoms and test results, with diseases associated with suchinformation. Such disease information may be stored on the laboratorysystem 40, or one or more separate database, and may be sourced frompublic and private data sources. For example, without limitation, ifchest pain is reported, a likely condition of heart disease may bedetermined.

The laboratory system 40 may identify one or more genetic markers thatmay have a bearing on the effectiveness of prescribed, or likely to beprescribed, treatments. The laboratory system 40 may determine whethertesting for the identified genetic markers fits one or more billingparameters. For example, without limitation, the laboratory system 40may determine whether such testing would be considered medicallynecessary under Medicare regulations and/or guidelines. An exemplarylisting of medically necessary codes is provided in tables 1-2 below.The provided tables are merely exemplary and are not intended to belimiting.

TABLE 1 Cardiovascular Diagnostic Codes Code Description 120.0 Unstableangina 120.1 Angina pectoris with documented spasm 120.8 Other forms ofangina pectoris 120.9 Angina pectoris, unspecified 121.09 ST elevation(STEMI) myocardial infarction involving other coronary artery ofanterior wall 121.11 ST elevation (STEMI) myocardial infarctioninvolving right coronary artery 121.19 ST elevation (STEMI) myocardialinfarction involving other coronary artery 121.29 ST elevation (STEMI)myocardial infarction involving other sites 121.3 ST elevation (STEMI)myocardial infarction of unspecified site 121.4 Non-ST elevation(NSTEMI) myocardial infarction 124.0 Acute coronary thrombosis notresulting in myocardial infarction 124.1 Dressler's syndrome 124.8 Otherforms of acute ischemic heart disease 124.9 Acute ischemic heartdisease, unspecified 125.110 Atherosclerotic heart disease of nativecoronary artery with unstable angina pectoris 125.700 Atherosclerosis ofcoronary artery bypass graft(s), unspecified, with unstable anginapectoris 125.710 Atherosclerosis of autologous vein coronary arterybypass graft(s) with unstable angina 125.720 Atherosclerosis ofautologous artery coronary artery bypass graft(s) with unstable anginapectoris 125.730 Atherosclerosis of nonautologous biological coronaryartery bypass graft(s) with unstable angina pectoris 125.750Atherosclerosis of native coronary artery of transplanted heart withunstable angina 125.760 Atherosclerosis of bypass graft of coronaryartery of transplanted heart with unstable angina 125.790Atherosclerosis of other coronary artery bypass graft(s) with unstableangina pectoris

TABLE 2 Psychiatric and Pain Management Diagnostic Codes CodeDescription F31.30 Bipolar disorder, current episode depressed, mild ormoderate severity, unspecified F31.31 Bipolar disorder, current episodedepressed, mild F31.32 Bipolar disorder, current episode depressed,moderate F31.4 Bipolar disorder, current episode depressed, severe,without psychotic features F31.5 Bipolar disorder, current episodedepressed, severe, with psychotic features F31.60 Bipolar disorder,current episode mixed, unspecified F31.61 Bipolar disorder, currentepisode mixed, mild F31.62 Bipolar disorder, current episode mixed,moderate F31.63 Bipolar disorder, current episode mixed, severe, withoutpsychotic features F31.64 Bipolar disorder, current episode mixed,severe, with psychotic features F31.75 Bipolar disorder, in partialremission, most recent episode depressed F31.76 Bipolar disorder, infull remission, most recent episode depressed F31.77 Bipolar disorder,in partial remission, most recent episode mixed F31.78 Bipolar disorder,in full remission, most recent episode mixed F31.9 Bipolar disorder,unspecified F32.9 Major depressive disorder, single episode, unspecifiedF33.0 Major depressive disorder, recurrent, mild F33.1 Major depressivedisorder, recurrent, moderate F33.2 Major depressive disorder, recurrentsevere without psychotic features F33.3 Major depressive disorder,recurrent, severe with psychotic symptoms F33.40 Major depressivedisorder, recurrent, in remission, unspecified F33.41 Major depressivedisorder, recurrent, in partial remission F33.42 Major depressivedisorder, recurrent, in full remission F33.9 Major depressive disorder,recurrent, unspecified G10 Huntington's disease

In exemplary embodiments, if any of the diagnostic codes provided by thehealthcare provider system 50 fit the provided billing parameters, thenthe genetic testing may automatically be included in the plan oftreatment for that patient.

Alternatively, or additionally, the laboratory system 40 may beconfigured to gather and review insurance information for coverageeligibility for particular types of testing. The laboratory system 40may be configured to determine whether such testing would be wholly orpartially covered by the user's insurance. This may be performed byreviewing the billing codes against those codes covered by the user'sinsurance. This may alternatively or additionally be performed byinterfacing with the user's insurance provider. Regardless, in suchembodiments, the billing parameters may comprise the testing known orlikely to be approved. These billing parameters may be predetermined andpreprogrammed and may be selected based on the user's insurancecoverage.

Alternatively, or in addition, the laboratory system 40 may beconfigured to generate one or more forms for gathering and authorizingpayment information for desired testing. For example, withoutlimitation, the laboratory system 40, or a separate payment system, maybe configured to store and authorize credit card transactions to pay forthe ordered testing. This option may be provided to, for example withoutlimitation, users who do not have insurance or elect not to billinsurance for such testing. This option may also be provided to coverany co-payment, patient responsible portions, some combination thereof,or the like. In such cases, the billing parameters may be any testingelected by the user. The generated forms may be electronic in nature andmay be generated by the laboratory system 40 for display to the user andreturn to the laboratory system 40 for storage, though such is notrequired.

If the test fits the billing parameters, an option to order testing maybe presented to the healthcare provider at the healthcare providersystem 50. If not, then the test for the next genetic marker may beconsidered. Alternatively, or additionally, if the test fits the billingparameters, it may be automatically added to a list of ordered tests.The presentment of options to order testing may be controlled by thelaboratory system 40, though such is not required.

If the healthcare provider orders the test, or the test is automaticallyadded, the appropriate wells 32 may be added to, or removed from, thetesting device 30 to test for the specified genetic markers.Alternatively, or in addition, the appropriate wells 32 may be blockedor unblocked on the testing device 30 to test for the specified geneticmarkers. Once all identified tests are considered, instructions forassembly of the testing device 30 may be transmitted and the testing maybe performed.

In exemplary embodiments, user information may be gathered, orpresented, using one or more secured means. For example, withoutlimitation, information may be gathered and entered into the personalelectronic devices 51 running a secured browser application. Thepersonal electronic devices 51 may comprise remote shunt downcapabilities and a variety of security protocols, such as but notlimited to, authentication, biometric scanning, single sign-on, barcodescanning protocols, some combination thereof, or the like may beutilized.

Other information gathered from the user may include scanned copies ofinsurance card and photo ID. Forms such as digital consent forms,educational information, questionnaires, and medical necessity forms maybe digitally filled out, stored, and/or transmitted. The laboratorysystem 40 and/or the healthcare provider system 50 may be configured togenerate a QR code, barcode, label, or other identifier for attachmentto the genetic material gathering device 10, the genetic testing device,paperwork, some combination thereof, or the like. Scanning of the QRcode, barcode, label, or another identifier may automatically retrievethe associated user information.

FIG. 5B is a flow chart illustrating other exemplary logic foridentifying and ordering tests. Diagnostic and/or procedure codes may beentered by the healthcare provider. Preferably, such diagnostic and/orprocedures codes are entered at the respective personal electronicdevice 51 for the respective healthcare provider system 50. Thediagnostic and/or procedure codes may conform to InternationalClassification of Diseases (“ICD”), though any type, standard, protocol,etc. of coding is contemplated. If the diagnostic and/or procedure codesmeet medically necessary criteria for a given genetic efficacy test, forexample without limitation, then the test may be automatically added toa list of ordered tests to be transmitted to the laboratory system 40.If the diagnostic and/or procedure codes fail to meet medicallynecessary criteria, for example without limitation, then the next testmay be considered until all possible tests are exhausted.

Once all tests are considered, the list of order tests may betransmitted to the laboratory system 40. The diagnostic and/or procedurecodes may be utilized to determine which genetic efficacy tests arerelevant. In other exemplary embodiments, a list of particular genetictests may be considered for each patient. The medically necessarycriteria may be under Medicare and/or Medicaid guidelines, though anyprotocol, standard, or the like is contemplated. Other criteria arecontemplated in addition to, or as an alternative to, the medicallynecessary criteria.

In this way, eligible test results may be automatically added to anorder. Being a cutting-edge field, genomic efficacy testing is sometimesunknown or under considered by healthcare providers. The disclosedsystems and methods not only permit the determination of insuranceeligibility for such testing, but may automatically add such eligibletests to help ensure that a patient receives the highest quality of careand maximizes the information available to healthcare providers.

FIG. 6A is a flow chart illustrating exemplary logic for performinggenetic efficacy testing and analyzing results. Genetic material fromthe user may be gathered by way of the genetic material gathering device10. A genetic testing device 30 comprising wells 32 for the orderedtesting may be assembled. Such assembly may be performed manually orautomatically. Such assembly may be performed concurrently, before, orafter obtaining the genetic material. The genetic material may then besequenced using the genetic sequencing device 20.

The testing may determine the presence or non-presence of the geneticmarkers for which the testing is performed. The results of such testingmay be transmitted to the laboratory system 40. The results may becompared against information stored in the laboratory system 40, orelsewhere, regarding the effectiveness of given treatment options, suchas but not limited to medications, in persons having or not havingparticular genetic markers. In particular, the results may be comparedfor each of the treatments prescribed to the user, or likely to beprescribed to the user. Similarly, the results may be compared againstinformation stored in the laboratory system 40, or elsewhere, regardingthe need for particular dosages or treatments in persons having or nothaving particular genetic markers. In particular, the results may becompared for each of the treatments and/or dosages prescribed to theuser, or likely to be prescribed to the user. Such information may begathered from one or more public or private sources such as, but notlimited to, the human genome project. In exemplary embodiments, thelaboratory system 40, the healthcare provider system 50, and/or anothersystem may be configured to prompt the healthcare provider to perform afollow-up telephone call regarding the test results a period of timeafter electronically transmitting the results to the patient.

The laboratory system 40 may be configured to flag ineffectivetreatments and/or dosages. Likewise, the laboratory system 40 may beconfigured to flag effective treatments and/or dosages. In exemplaryembodiments, the results may be color coded. For example, withoutlimitation, red color coding may indicate an ineffective treatmentand/or dosage. A yellow color coding may indicate the need to adjust thetreatment and/or dosage or monitor use of the therapy. A green colorcoding may indicate that the treatment and/or dosage is acceptable.Other colors and types of coding are contemplated.

The results of the testing may be transmitted to the healthcare providersystem 50. The laboratory system 40 may be configured to automaticallysuggest alternative medications, or dosages, or treatment options forthose treatments flagged to be ineffective or requiring adjustments.Furthermore, the healthcare provider system 50 may be updated to reflectthe ineffectiveness of the treatments and/or dosages. For example,without limitation, ineffective treatments may be flagged or otherwisecoded as an allergy in the user's file. More specifically, ineffectivetreatments may be identified in the message to the healthcare provider.For example, without limitation, this information may be added to theHL7 electronic results, such as but not limited to the PathX HL6electronic communication, that are received with the test results andembedded into any .pdf type files generated from the HL7 file.

Alternatively, or in addition, additional parties may be notified oftreatments and/or dosages determined to be ineffective. Such parties mayinclude, but are not limited to, pharmacists, project managers,healthcare practice administrators, insurance providers, users, otherhealthcare providers, other approved persons, and the like. The resultsof the testing may be transmitted to each parties' respective system 50.

One or more healthcare information exchanges (“HIEs”) may be utilized toprovide information between various systems 50 and individuals. Forexample, without limitation, the results of the testing mayautomatically be shared with the healthcare provider system 50 for eachhealthcare provider treating the user. Each healthcare provider treatingthe user may automatically be granted access to the results of thetesting, such as by way of the respective healthcare provider's personalelectronic device 51. In exemplary embodiments, the HIE may providetwo-way communication such that information may be transmitted to andfrom the laboratory system 40.

FIG. 6B is a flow chart illustrating exemplary logic for integratinggenetic efficacy test results within existing healthcare providersystems 50. Existing healthcare providers system 50, such as but notlimited to EHRs, may not have a dedicated space for the integration ofgenomic testing results. Redesigning existing systems to provide such adedicated space would be time consuming and expensive. As such, inexemplary embodiments, after receiving the genetic efficacy testingresults and determining which treatment options are ineffective and/orhave a reduced efficacy, such treatment options may be designated as anallergy in the user's file. Many, if not all, existing healthcareprovider systems 50 have a designated space for the notation ofallergies. As such, this provides a pathway for integration of genomicefficacy testing results into the patient's electronic file. Helpfully,in many cases, the healthcare provider system 50 is configured to raisean alert or otherwise provide some kind of notification uponprescription of such treatments flagged as an allergy. In this way, forexample without limitation, ineffective medications and/or dosages maybe alerted to the healthcare provider when ordering at the healthcareprovider system 50.

FIG. 7 is an exemplary healthcare provider interface 60. The healthcareprovider interface 60 may be displayed on one or more personalelectronic devices 51 in electronic communication with the healthcareprovider system 50. The personal electronic devices 51 may includecomputers, smartphones, tablets, some combination thereof, or the like.The interface 60 may provide results for one or more patients. Theinterface 60 may alternatively, or in addition, provide the results formultiple medications for a one or more patients. In exemplaryembodiments, the results may be presented with the clinical consequencesof prescribing each of the therapies. For example, without limitation,the interface 60 may inform the healthcare provider of whether theprescribed therapy is likely to be effective, partially effective,wholly ineffective, or the like. The healthcare provider interface 60may be updated for each individual healthcare provider user 62. Thehealthcare provider's recently accessed files may be identified 64. Aquick links section 66 may include a link to the portal for testordering and results. A schedule 68 may include one or more indicators70 which patient(s) have possible warnings associated with their testresults. For example, without limitation, the results may be colorcoded. Such warnings may be provided as a result of coding theineffective treatment options as an allergy in the user's file.

In other exemplary embodiments, indicators 70 may be presented in theform of alerts. Such alerts may include pop-ups, warning signals,electronic messages, some combination thereof, or the like. Suchindicators 70 may be generated upon the receipt of results whichindicate that the healthcare provider has prescribed a treatment, suchas but not limited to a drug, to a patient known to be a non-responderto such treatments, the presence of abnormal result or range, theprescription of a treatment known to cause an allergic effect in thepatient, or the prescription of a treatment which may potentially causean interaction with a drug previously prescribed to the patient, or witha disease the patient is diagnosed with as understood in view of theanalyzed genetic information. Other clinical information may betransmitted and displayed on the interface 60 such as, withoutlimitation, an explanation of the results.

FIG. 8 is a simplified block diagram illustrating exemplary logic foranalyzing genetic efficacy test results and generating alerts. Once theresults of the genetic analysis are received, they may be reviewed. Thereview may include a comparison against information known about thepatient, for example, by analyzing the patient's medical records asstored at one or more of the healthcare provider systems 50. Forexample, without limitation, the results may be reviewed to determine ifthe healthcare provider has prescribed, or is likely to prescribe, atreatment, such as but not limited to a drug, to a patient known to be anon-responder to such treatments, if the results include an abnormalresult or range, if the healthcare provider has prescribed a treatmentknown to cause an allergic effect in the patient, and/or if thehealthcare provider has prescribed a treatment which may potentiallycause an interaction in view of the analyzed genetic information. Theclinical information required to support this analysis may be retrievedfrom one or more databases, such as but not limited to, the healthcareprovider system 50 or a database comprising various known medicalinformation such as known drug interactions based on genetic makeup,normal results or ranges for various medical tests, and the like. Theresults of this review may be used to code the results displayed at theinterface 60 or generate alerts as appropriate.

The comparison, analysis, and the like described herein may be performedat the laboratory system 40 or at the healthcare provider system 50. Itis contemplated that any type of clinical information may be transmittedfor display at the interface 60. The genetic information and testresults may be stored at the laboratory system 40, the healthcareprovider system 50, and/or another system to also be used against futureprescribed treatments. In this way, the testing results may stay withthe patient such that they can be referred to in the future as aperson's genetic makeup generally remains unchanged throughout theirlife.

The clinical consequence of prescription, in exemplary embodiments, maybe added to the electronic results and embedded into a single file fortransmission to the healthcare provider system 50, though multiple filesmay be utilized. This may remove the need for use of multiple file typesbetween the laboratory system 40, the healthcare provider system 50, andthe electronic displays or individual systems 51. This mayalternatively, or in addition, remove the need for multiple file typesto be transmitted to one of the aforementioned systems. For example, onefile with the results and another file with any alerts or other clinicalinformation, though such an embodiment is contemplated. In exemplaryembodiments, the results and all other related clinical information maybe transmitted in a single standardized file, such an HL7 type file,though any file type is contemplated. This may permit the report to beintegrated into any EHR system. In other exemplary embodiments, suchclinical consequences may be transmitted by designating the particulartreatment options likely to be ineffective or undereffective as anallergy. In exemplary embodiments, the genetic information and/or testresults may be temporarily stored at the laboratory system 40 and/oranother electronic storage device such that the data may be reformattedor otherwise modified as required to integrate with the HIE 55 and/orthe various healthcare provider systems 50.

The coding and alerts described herein may be individualized based onthe preferences of each user or entity. For example, when communicatingresults to a first healthcare provider system 50, alerts may begenerated only when certain predetermined conditions are met. Likewise,when communicating results to a second healthcare provider system 50alerts may be generated only when other predetermined conditions are metwhich may be the same or different from (with some overlap, completeoverlap, or no overlap) with the predetermined conditions used togenerate alerts for communications to the first healthcare providersystem 50. Similarly, preferences may be altered for each personalelectronic device 51.

In exemplary embodiments, the results may be transmitted along witheducational information regarding the genetic testing results, a spacefor progress notes, and order information. In exemplary embodiments, thelaboratory system 40, the healthcare provider system 50, or anothersystem, may automatically schedule a follow up telephone encounter forapproximately 1 week after the results are transmitted or the order isplaced for testing.

FIG. 9 illustrates an exemplary laboratory based prior authorizationsystem 100. FIG. 10 illustrates exemplary logic for operating the system100. The system 100 may comprise one or more healthcare provider officesystems 102. The healthcare provider office system 102 may comprise oneor more EHR systems 104, though the use of EMRs is also contemplated.While illustrated as part of the healthcare provider system 102, the EHR104 may be separate from, and in electronic communication with, thehealthcare provider office system 102. The healthcare provider officesystem 102 may comprise, alternatively or additionally, one or moretelephones, fax machines, personal electronic devices, displays,databases, servers, some combination thereof, or the like. The EHRsystem 104 may comprise health information regarding one or morepatients. The EHR system 104 may comprise medications, diagnoses,insurance information, identifying information, medical historyinformation, billing information, contact information, some combinationthereof, or the like.

The healthcare provider office system 102 may be in electroniccommunication with a laboratory system 106. The laboratory system 106may comprise a Laboratory Information System (“LIS”) 108. The laboratorysystem 106 may comprise, alternatively or additionally, one or moretelephones, fax machines, personal electronic devices, displays,databases, servers, some combination thereof, or the like. Thelaboratory system 106 may comprise one or more genetic sequencingdevices 120. The genetic sequencing devices 120 may each be inelectronic communication with the LIS 108. The genetic sequencingdevices 120 may each be the same or similar to genetic sequencingdevices 20 shown and described with respect to FIG. 2. The geneticsequencing devices 120 may each comprise a controller, which may includethe same or similar to the control panel 24 shown and described withrespect to FIG. 2, though such is not required.

Order information may be transmitted from the healthcare provider officesystem 102 to the laboratory system 106. The order may be transmitted inelectronic form. In exemplary embodiments, the order may comprise an HL7order. The order may be transmitted from the EHR 104 to the LIS 108,though such is not required. A specimen for the order may be transmittedfrom the healthcare provider office system 102 to the laboratory system106. The specimen may comprise the genetic material gathering device 10,which may comprise genetic material for testing. In other exemplaryembodiments, optical recognition software may be utilized to recognizeand input order information.

It is notable that any number of healthcare provider offices 102 may beutilized and be in electronic communication with the laboratory system106. Each healthcare provider office system 102 may have its own EHRsystem 104 or may share EHR systems 104 with other healthcare provideroffice systems 102.

The order may be transmitted electronically. The laboratory system 106may receive the order and automatically parse the data to generate oneor more prior authorization requests. In exemplary embodiments, theorder may be transmitted from the EHR 104 and/or received at the LIS108, which may be configured to perform the electronic parsing and priorauthorization request generation. In exemplary embodiments, theelectronic parsing and prior authorization request generation may beperformed by an automated pre-approval request engine 109. The parseddata may comprise, for example without limitation, identificationinformation, demographic information, insurance information, orderinformation, diagnosis information, current procedural terminology (CPT)information, active medications for the patient, some combinationthereof, or the like. At least some of this information may,alternatively or additionally, be obtained by electronic query of theEHR system 104. Retrieval from the EHR system 104 may ensure that themost updated information is being utilized. Updated information may beautomatically utilized without the need to send a redundant update tothe LIS 108 as such updated information may be automatically retrievedand integrated.

In exemplary embodiments, the active medication and/or diagnosisinformation may be obtained from the EHR 104 and may facilitate theability for the payor or prior authorization provider 110 to determinethe medical necessity of the ordered testing. The prior authorizationrequest may comprise the data parsed from the incoming genetic testsorder and/or information retrieved from the EHR 104. The LIS 108 may beconfigured to retrieve such data and generate a prior authorizationrequest formatted in the fashion desired by the payor or priorauthorization provider 110. In this way, the laboratory system 106 maybe positioned to automatically obtain prior authorization withoutadditional involvement of the healthcare provider office system 102.This may prevent the undue duplication of data at both the healthcareprovider office system 102 and the laboratory system 106. In exemplaryembodiments, such information may be retrieved, parsed, formatted, andtransmitted by the automated pre-approval request engine 109, thoughsuch is not required.

In exemplary embodiments, the LIS 108 may be configured to generate andsubmit a prior authorization request before an order is submitted. Forexample, without limitation, the LIS 108 may be prompted by thehealthcare provider office system 102 to review a specific patient filefor eligible genetic tests. As another example, without limitation, theLIS 108 may be configured to review new entries made at the EHR 104 foreligible genetic tests. In such cases, the same or substantially thesame, systems and methods may be utilized to obtain prior authorizationand generate a list of eligible tests in the form of a proposed orderwhich is transmitted to the healthcare provider office system 102 forapproval. The EHR 104 may be configured to display the proposed orderfor affirmation by the healthcare provider. In other exemplaryembodiments, the proposed order may be automatically placed.

The parsed information may be automatically transformed into one or moreprior authorization requests. The prior authorization request(s) may betransmitted from the laboratory system 106 to the payor or priorauthorization provider 110. The payor or prior authorization provider110 may process the prior authorization request(s) and return areference identifier and/or patient responsibility amount to thelaboratory system 106. For example, without limitation, the patientresponsibility may comprise a monetary amount due, a copayment, adeductible, coinsurance, a denial of coverage, an approval of coverage,a percentage of costs due, a negotiated price, an amount covered, somecombination thereof, or the like. The reference identifier may comprisea number, code, or other unique identifier.

The patient responsibility may be determined by applying one or morepolicy rules. The policy rules may be stored at a database. The policyrules may comprise eligibility determinations based on the orderedtests, diagnostic codes, treatment codes, some combination thereof, orthe like. The policy rules, additionally or alternatively, may comprisemedically necessary criteria. The policy rules may comprise patientresponsibility rules, such as not but not limited to, co-pays,coinsurance, deductibles, negotiated rates, some combination thereof, orthe like. The policy rules may be specific to various policies providedby the payor. The payor or prior authorization provider 110 may beconfigured to retrieve the policy rules based on the patient informationand/or insurance information received and apply the policy rules to theordered tests to determine eligibility and patient responsibility.

Where the patient responsibility is below a predetermined threshold, theLIS 108 may be configured to transmit instructions to the geneticsequencing device 120 to initiate the ordered testing. Upon completion,the results may be returned from the genetic sequencing device 120 tothe LIS 108. The LIS 108 may be configured to transmit the results, suchas but not limited to, in notification, instruction, and/or report form,to the EHR system 104. For example, without limitation, thepredetermined threshold may be $50 USD. Any amount may be utilized forthe predetermined threshold. Where the patient responsibility is abovethe predetermined threshold, a call center notice may be automaticallygenerated by the laboratory system 106 and transmitted to a call centersystem 112. The call center notice may be transmitted from the automatedpre-approval request engine 109, in exemplary embodiments. In exemplaryembodiments, the automated pre-approval request engine 109 and/or theLIS 108 may be in direct electronic communication with the payor orprior authorization provider 110.

The call center notice may comprise information from the parsed dataand/or returned from the payor or prior authorization provider 110. Suchinformation may be communicated to the automated pre-approval requestengine 109, in exemplary embodiments. In exemplary embodiments, anelectronic notification may be automatically generated with call centernotices for all claims received from the payor or prior authorizationprovider 110 in a given period of time. The electronic notification maybe transmitted to the call center system 112. The call center system 112may be provided at the laboratory 106 or may be remote therefrom. Forexample, without limitation, an encrypted email may be automaticallygenerated periodically with attached call center notices for all claimsprocessed by the payor or prior authorization provider 110 in a periodof time, such as but not limited to the prior 1-24 hours. Any timeperiod is contemplated such as, but not limited to, 4 hours, 12 hours,24 hours, some combination thereof, or the like. In this way, one maysimply check to see that the electronic notifications are beingperiodically transmitted to verify that the system is functioningproperly. This may result in consistent, faster data processing.

The call center system 112 may be configured to contact the patient 116and inform the patient 116 of the patient responsibility required toproceed. The call center system 112 may comprise one or more automaticdialers, text message generators, email generators, some combinationthereof, or the like. For example, without limitation, the call centersystem 112 may be configured to automatically extract patient contactinformation, such as but not limited to, phone numbers, email addresses,some combination thereof, or the like, and automatically generatemessages and/or dial, text, email, some combination thereof, or the likethe patient to obtain the patient's consent to proceed.

Payment information may be collected and/or processed by a paymentprocessing system 114. The payment processing system 114 may be internalto the call center system 112 or external. The payment informationcollected and/or processed may comprise credit card information, debitcard information, electronic checks, wire information, bank accountinformation, some combination thereof, or the like. The paymentprocessor 114 may be configured to process the payment informationreceived. The payment processing system 114 may return confirmation ofpayment. The funds may be electronically transferred to a financialinstitution 118, such as but not limited to a bank, associated with thelaboratory system 106. In this way, the number of parties having accessto sensitive financial information is reduced. This may prevent the needto transmit funds between multiple institutions. This may reduce thenumber of access points to sensitive financial information, therebyincreasing data security.

Where the patient 116 elects not to proceed with the ordered testing,notification regarding the same may be transmitted from the LIS 108 tothe EHR 106. Such notification may additionally be transmitted from thecall center system 112 to the LIS 108. In exemplary embodiments, where apredetermined number of contact attempts are made from the call centersystem 112 to the patient 116, and no reply is received, the patient 116may be deemed to have not consented. For example, without limitation,the predetermined number of attempts may be three attempts. The callcenter system 112 may be configured to automatically track the number ofattempted contacts. For example, without limitation, an automated dialerat the call center system 112 may be configured to extract andautomatically dial the user three times, if no call is picked up, theuser may be deemed to have not consented. Upon receipt of notificationof denial of consent (whether through explicit denial, lack of abilityto contact patient, or otherwise) the specimen may be destroyed. Forexample, without limitation, the call center system 112 may beconfigured to generate an electronic notification regarding the denialwhich is transmitted to the LIS 108, which in turn generatesinstructions to destroy the specimen.

Upon receipt of notification of consent and/or payment, the LIS 108 maygenerate instructions to the genetic sequencing device 120 to begintesting the specimen. For example, without limitation, the call centersystem 112 may be configured to generate an electronic notificationregarding the consent and/or payment which is transmitted to the LIS108, which in turn generates instructions to proceed with the orderedtesting. The specimen may be analyzed and results regarding the same maybe generated and transmitted to the LIS 108. The LIS 108 may transmitthe results to the healthcare provider office system 102. For example,without limitation, the LIS 108 may integrate the testing results intothe EHR 104. In exemplary embodiments, the testing may comprisemedication efficacy testing and the LIS 108 may be configured to flagineffective medications as allergies at the patient file at the EHR 104.

The LIS 108 may be configured to determine, from the informationobtained from the payor or prior authorization provider 110, any paymentowed by the payor or prior authorization provider 110 and may beconfigured to be automatically generate an invoice with the owned amountand transmit the invoice the payor or prior authorization provider 110with the reference number and other necessary information. The callcenter notices may comprise the reference number for tracking purposes.In exemplary embodiments, the invoice may be generated and transmittedelectronically. In this may, payment may be secured by the laboratorywithout intervention by the healthcare provider office and/or the user.This may reduce the need for duplicate invoicing information whichotherwise would be sent to the healthcare provider and then on to thepayor, thereby reducing burdens on sever use and electronic storage.

The transmissions, receipts, parsing, generation, and the like shownand/or described herein may be accomplished electronically. This mayreduce or eliminate the number of human interactions required. This mayreduce the potential for error and/or speed up data processing. Forexample, without limitation, the system may be configured to achieve anerror rate of less than 1%. This may reduce the need for certainhealthcare provide resources, thereby reducing costs and complexity. Theentire process may be completed while the specimen is in transit to thelaboratory system 106, though such is not required. The specimen, uponarrival, may be associated with the reference number for trackingpurposes. Such association may be made by way of a barcode, QR code,label, identifier, some combination thereof, or the like which may bephysically associated with the specimen.

The LIS 108 may comprise data indicating prior authorization providersassociated with various insurance providers such that the insuranceprovider may be contacted directly, or prior authorization provider maybe contacted when appropriate. Such data may be stored at one or moreremote databases.

The predetermined amount which triggers contacting the patient tocollect payment may be specified in a consent document. The billingconsent document may be provided to the healthcare provider officesystem 102. The billing consent document may be signed at the same timethe specimen is collected, and may inform the patient that they may ormay not receive a call in the next day or so. The consent document maybe provided in electronic form and may be electronically returned to theLIS 108 for recordation. The consent document may be electronicallygenerated by the LIS 108 and electronically transmitted to thehealthcare provider office system 102, such as but not limited to by wayof the EHR 104, for patient 116 signature though such is not required.In other exemplary embodiments, a paper or other copy of the consentdocument may be provided to the patient and may be scanned or otherwiseconverted to electronic form for storage. The consent document may formpart of the proposed or suggested order, though such is not required.

While certain systems, such as but not limited to the call center system112, the payment processing system 114, are illustrated as separate fromthe laboratory system 106, such systems may be integrated with thelaboratory system 106 and may be provided as subsystems of the LIS 108,for example.

Any embodiment of the present invention may include any of the optionalor preferred features of the other embodiments of the present invention.The exemplary embodiments herein disclosed are not intended to beexhaustive or to unnecessarily limit the scope of the invention. Theexemplary embodiments were chosen and described in order to explain theprinciples of the present invention so that others skilled in the artmay practice the invention. Having shown and described exemplaryembodiments of the present invention, those skilled in the art willrealize that many variations and modifications may be made to thedescribed invention. Many of those variations and modifications willprovide the same result and fall within the spirit of the claimedinvention. It is the intention, therefore, to limit the invention onlyas indicated by the scope of the claims.

Certain operations described herein may be performed by one or moreelectronic devices. Each electronic device may comprise one or moreprocessors, electronic storage devices, executable softwareinstructions, and the like configured to perform the operationsdescribed herein. The electronic devices may be general purposecomputers of specialized computing device. The electronic devices may bepersonal computers, smartphone, tablets, databases, servers, or thelike. The electronic connections described herein may be accomplished bywired or wireless means. The computerized hardware, software,components, systems, steps, methods, and/or processes described hereinmay serve to improve the speed of the computerized hardware, software,systems, steps, methods, and/or processes described herein.

What is claimed is:
 1. A system for laboratory-based authorization ofgenetic testing, said system comprising: a healthcare provider officesystem comprising an electronic health record (“EHR”) system; alaboratory system comprising a laboratory information system (“LIS”),wherein said LIS is in electronic communication with said EHR system;software instructions, stored at one or more electronic storage devicesof the LIS, which when executed, configure one or more processors of theLIS to: receive an order from the healthcare provider office system,wherein said order comprises patient identifier, insurance information,and genetic testing to be performed for a patient; query the EHR systemto retrieve active medications and diagnosis associated with the patientidentifier; automatically parse data from the received order and the EHRsystem to generate a prior authorization request; transmit, to a priorauthorization provider associated with the received insuranceinformation, the prior authorization request; receive, from the priorauthorization provider, a reference number and patient responsibilityamount for the prior authorization request; where the patientresponsibility amount is above a predetermined threshold: generate andtransmit an electronic call center notice to a call center system inelectronic communication with the LIS, said electronic call centernotice comprising a patient name, patient contact information, and thepatient responsibility amount; and contacting the patient by way of thecontact information to obtain payment for the patient responsibilityamount; where no payment is received at the call center system,receiving, from the call center system, an electronic notification todestroy a specimen associated with the order; where an indication ofreceived payment is received from the call center system or the patientresponsibility amount is below the predetermined threshold: perform thegenetic testing; and integrate the test results into the EHR.
 2. Thesystem of claim 1 wherein: the genetic testing comprises medicationefficacy testing.
 3. The system of claim 2 wherein: said EHR isconfigured to automatically flag ineffective medications identified inthe report as an allergy in the EHR.
 4. The system of claim 3 furthercomprising: an alternatives database comprising alternative medications;and software instructions, stored at the one or more electronic storagedevices of the LIS, which when executed, configure the one or moreprocessors of the LIS to: query the alternatives database to retrievealternative medications for each of the identified ineffectivemedications; transmit the retrieved alternative medications to the EHRsystem.
 5. The system of claim 1 further comprising: the call centersystem; and a payment processing system in electronic communication withthe call center system and configured to receive and process credit cardinformation, electronically return payment confirmation to the callcenter system, and electronically transmit funds to a financialintuition associated with the laboratory system.
 6. The system of claim5 further comprising: software instructions, stored at the one or moreelectronic storage devices of the LIS, which when executed, configurethe one or more processors of the LIS to determine that a denial hasbeen received from the call center system when an electronicnotification from the call center system is received that apredetermined number of attempts have been made to contact the patientwithout success.
 7. The system of claim 1 wherein: the electronic orderis an HL7 order; and the call center notice is an attachment to anencrypted email.
 8. The system of claim 1 further comprising: a numberof additional healthcare provider systems, each comprising an EHR systemcomprising medical information for the patient; a healthcare informationexchange (“HIE”) interposed between the LIS, the EHR, and each of thenumber of additional EHRs; software instructions, stored at the one ormore electronic storage devices of the LIS, which when executed,configure the one or more processors of the LIS to integrate the testresults into the EHR systems for each of the number of additionalhealthcare provider systems by way of the HIE.
 9. The system of claim 4further comprising: a treatment protocol database comprising medicationsassociated with diagnoses, wherein said medications are those commonlyprescribed to treat the associated diagnosis; and software instructions,stored at the one or more electronic storage devices of the LIS, whichwhen executed, configure the one or more processors of the LIS to: querythe EHR to retrieve diagnoses for the patient; query the treatmentprotocol database to retrieve medications associated with the retrieveddiagnoses; and treat the retrieved medications as additional activemedications.
 10. A method for laboratory-based authorization of genetictesting, said method comprising the steps of: sending a specimencomprising genetic material for a patient stored at a genetic materialgathering device from a healthcare provider office to a laboratory;electronically transmitting an order for genetic testing of the specimenfrom an electronic health record (“EHR”) system associated with thehealthcare provider office to a laboratory information system (“LIS”)associated with the laboratory, wherein said order comprises a patientidentifier, insurance information, patient contact information, andgenetic testing ordered; electronically transmitting a patient consentdocument from the EHR to the LIS, wherein the patient consent documentis associated with the order; querying the EHR system by way of the LISto retrieve diagnoses and active medications associated with the patientidentifier; generating, at the LIS, an electronic prior authorizationrequest comprising the genetic testing ordered, the patient identifier,the insurance information, the retrieved diagnoses, and the retrievedactive medications; electronically transmitting, from the LIS, theelectronic prior authorization request to an insurance or priorauthorization provider associated with the insurance information; andelectronically receiving, from the insurance or prior authorizationprovider, a reference identifier and patient responsibility amount inresponse to the electronic prior authorization request.
 11. The methodof claim 10 further comprising the steps of: determining, at the LIS,that the patient responsibility amount exceeds a predetermined thresholddescribed in the patent consent document; generating, at the LIS, a callcenter notice comprising the patient contact information and the patientresponsibility amount; electronically transmitting the call centernotice to a call center system; obtaining payment from the patient byway of the call center system and a payment processing center; providingelectronic payment confirmation to the LIS from the call center system;instructing a genetic sequencing device, by way of the LIS, to performthe ordered genetic testing on the specimen; and electronicallyintegrating the results of the ordered genetic testing into the EHR. 12.The method of claim 11 wherein: the ordered genetic testing comprisesgenetic efficacy testing; and the results of the order genetic testingidentify effective and ineffective medications based on the patient'sgenetic makeup; and ineffective medications for the patient are flaggedas allergies at the EHR.
 13. The method of claim 12 further comprisingthe steps of: querying a database to retrieve an alternative medicationfor each ineffective medication; and identifying, at the EHR, thealternative medication for each ineffective medication.
 14. The methodof claim 13 further comprising the steps of: transmitting the results ofthe ordered genetic testing to a healthcare information exchange(“HIE”); and electronically integrating the results of the orderedgenetic testing into each of a number of additional EHRs, wherein eachof the number of additional EHRs are associated with another healthcareprovider treating the patient.
 15. The method of claim 10 furthercomprising the steps of: determining, at the LIS, that the patientresponsibility amount exceeds a predetermined threshold assigned in thepatent consent document; generating, at the LIS, a call center noticecomprising the patient contact information and the patientresponsibility amount; electronically transmitting the call centernotice to a call center system; attempting contact, by way of the callcenter system, to the patient contact information a predetermined numberof times without success; transmitting a notification to the LIS thatconsent was not obtained; and destroying the specimen.
 16. The method ofclaim 10 further comprising the steps of: determining, at the LIS, thatthe patient responsibility amount exceeds a predetermined thresholdassigned in the patent consent document; generating, at the LIS, a callcenter notice comprising the patient contact information and the patientresponsibility amount; electronically transmitting the call centernotice to a call center system; contacting the patient by way of thecall center system; recording a denial of consent from the patient atthe call center system; transmitting a notification to the LIS thatconsent was denied; and destroying the specimen.
 17. The method of claim11 further comprising the steps of: electronically transmitting thepayment information to a payment processor, wherein the paymentinformation comprises credit card information; and electronicallytransmitting funds to a financial institution associated with thelaboratory.
 18. The method of claim 17 wherein: the call centercomprises an automatic dialer; the call center notice comprises anattachment; the step of electronically transmitting the call centernotice to the call center comprises sending an encrypted emailcomprising the attachment to the call center; and the step of obtainingpayment from the patient by way of the call center and a paymentprocessing center comprises the sub-steps of: parsing the contactinformation from the attachment, wherein the contact informationcomprises a phone number; automatically dialing the phone number; andrecording the credit card information verbally provided by the patient.19. The method of claim 9 wherein: the reference number and the patientresponsibility amount are received prior to receipt of the specimen atthe laboratory.
 20. A system for laboratory-based authorization forgenetic based medication efficacy testing, said system comprising: anumber of healthcare provider systems, each comprising an electronichealth record (“EHR”) system comprising diagnoses and active medicationsfor a number of patients; a laboratory system comprising a laboratoryinformation system (“LIS”) in electronic communication with each of thenumber of healthcare provider systems and their respective EHR systemsand genetic sequencing devices in electronic communication with the LIS,wherein said LIS comprises an automated pre-approval request engine; adatabase in electronic communication with the LIS comprising medicationsknown to be wholly or partially ineffective in persons having particulargenetic markers; a prior authorization provider system in electroniccommunication with the LIS; a call center system in electroniccommunication with the LIS; and a payment processing system inelectronic communication with the call center system; wherein saidautomated pre-approval request engine is configured to, for each of anumber of received electronic HL7 orders: query the EHR associated withthe ordering healthcare provider system to retrieve active medicationsand diagnosis associated with a patient identifier provided in theorder; automatically parse the patient identifier, insurance policyinformation, and ordered testing from the electronic HL7 order anddiagnoses and active medications from the EHR to generate a priorauthorization request; electronically transmit, from the LIS to theprior authorization provider, the prior authorization request; receive,from the prior authorization provider at the LIS, a reference number andpatient responsibility amount for the prior authorization request; foreach of the number of received electronic HL7 orders having a patientresponsibility amount below a predetermined threshold: instructing, byway of the LIS, one of the genetic sequencing devices to perform theordered testing on a specimen received for the respective order todetermine the patient's genetic makeup; query the database to retrievemedications known to be wholly or partially ineffective in personshaving the same genetic makeup as the patient; determine, at the LIS, ifone or more of the active medications match the retrieved medications;integrate testing results into the EHR of the healthcare provider officeby flagging ineffective medications as allergies; for each of the numberof received electronic HL7 orders having a patient responsibility amountabove a predetermined threshold: transmit an encrypted email comprisingpatient contact information and the patient responsibility amount fromthe LIS to the call center system; contact the patent contactinformation by way of the call center system to request payment for thepatient responsibility amount; where payment is not received from thepatient, provide a notification to the LIS to destroy the specimen forthe respective order; and wherein payment is received: instructing, byway of the LIS, one of the genetic sequencing devices to perform theordered testing on a specimen received for the respective order todetermine the patient's genetic makeup; query the database to retrievemedications known to be wholly or partially ineffective in personshaving the same genetic makeup as the patient; determine, at the LIS, ifone or more of the active medications match the retrieved medications;and integrate testing results into the EHR of the healthcare provideroffice by flagging ineffective medications as allergies.